CUI (Clinical Utility Index)

1. Description

CUI provides a framework in assessing BR balance of drugs under development when measured over a range of doses or time. It is defined over (0,1) range and calculated as . CUI was developed to assess the therapeutic index of new drugs.

2. Evaluation

2.1 Principle
  • The clinical utility index is derived from specific desirability functions.
  • Its statistical distributions have not been studied.
  • The derivation of the index requires more extensive knowledge and understanding of mathematical concepts.
  • Its framework follows four broad steps:
    exposure-response analysis of benefits and risks endpoints;
    definition of criteria to define clinically meaningful changes;
    selection of important attributes and definition of relative weights;
    sensitivity analysis and measurement of uncertainty.

2.2 Features
  • CUI accommodates and integrates benefits and risks criteria.
  • When a criterion is totally unacceptable (valued as zero), CUI ignores the criterion.
  • This criterion for clinical relevance measures the fractions of patients helped by the drug rather than demonstrating an improvement for the average patient.

2.3 Visualisation
The visualisation associated with CUI is:
  • 2.4 Assessability and accessibility
  • The parameters and results are acceptable given the choice of the utility functions is acceptable.
  • CUI is interpreted as the excess or net benefit having accounted for risks.

3. References

[1] Ouellet D. Benefit-risk assessment: the use of clinical utility index. Expert Opin Drug Saf 2010 Mar;9(2):289-300.
[2] Ouellet D, Werth J, Parekh N, Feltner D, McCarthy B, Lalonde RL. The use of a clinical utility index to compare insomnia compounds: a quantitative basis for benefit-risk assessment. Clin Pharmacol Ther 2009 Mar;85(3):277-82.